Specialist - QA Shop Floor

About the role

The QA Specialist within the Quality Assurance Shop Floor organization provides quality oversight for routine clinical and commercial cell therapy operations, ensuring adherence to current Good Manufacturing Practices (cGMP). This role serves as a subject matter expert (SME) in cGMP, Good Documentation Practices (GDocP), and Data Integrity/ALCOA+ principles, supporting quality risk management and right-first-time execution on the Shop Floor at BMS Bothell. This position reports to QA Shop Floor Manager. Schedules : Quad 2 : 1:30pm to Midnight (Sun-Wed) Quad 4 : 1:30pm to Midnight (Wed-Sat) Quad 2 Overnight : 6pm to 6:30 am (Sun-Tue, + alternating Wed) Quad 3 : 6am to 4:30 pm (Wed-Sat) Duties/Responsibilities: Perform real-time review of executed batch records to ensure compliance with procedures; collaborate with manufacturing teams to resolve discrepancies. Observe manufacturing operations and identify departures from clean room behaviors, aseptic techniques and cGMP practices through QA Walkthroughs, Gemba and Process Observations. Own, review and approve moderate to complex operational documents such as Standard Operating Procedures (SOPs) and Work Instructions Represent QA and execute tasks in continuous improvement initiatives, including Kaizen events, 5S activities, and cross-functional gemba. Lead deviation triage activities, ensuring quality events are assessed through a process- and risk-based lens; drive timely and coordinate closure of NI/RCA events aligned with quality performance metrics. Job Requirements & Qualifications: Education: Bachelor's degree in STEM (Science, Technology, Engineering and Math education) field preferred. Associates degree with equivalent combination of education and work experience may be considered.

Requirements

• 3-4 years of GxP or equivalent experience in a regulated environment such as pharmaceuticals, medical devices, laboratory, biotechnology, or cell therapy manufacturing.
• Experience in batch record review, deviation management, and/or product disposition is preferred.
• Proficient in Microsoft Office applications (Word, Excel) and demonstrated proficiency in manufacturing systems such as MES, ERP (SAP), Deviation Management (Infinity) and Document Management (BMSDocs)
• Strong attention to detail with effective organizational, planning, and time management skills.
• Familiarity with quality risk management principles and ability to make sound, risk-based decisions, escalating critical issues appropriately.
• If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
• Compensation Overview:
• Bothell - WA - US: $38.42 - $46.55per hour
• Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
• Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include:
• Paid Time Off
• US Exempt

Benefits

Additional Information

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

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